Sr. Manufacturing Engineer

The Role

The Sr. Manufacturing Engineer is responsible for all technical activities related to product manufacturing, both internally and at external suppliers and contract manufacturers.  Activities typically include assembly tooling and fixture design, manufacturing process development and validation, design transfer into manufacturing, troubleshooting and sustaining engineering, and continuous improvement.  He/she must be a hands-on contributor with the ability to deliver business results in a fast-paced and dynamic environment.  Collaboration with Operations, R&D, and Quality Assurance will be essential to ensure timely resolution of supply chain and production-related issues.  
                                                                                                                                                
The Responsibilities
 
                                                                                              
  • Coordinate the design of production fixtures and tooling and specify production equipment, ensuring they meet safety, quality, capacity, and cost requirements
  • Work with internal employees and suppliers to develop, implement, monitor, and improve manufacturing processes using best practice tools such as Failure Modes and Effects Analysis (FMEA), Gage Repeatability and Reproducibility (GR&R), Design of Experiments (DOE), Verification and Validation (V&V), Statistical Process Control (SPC), and other data-driven techniques
  • Create, update, and maintain production documentation, including but not limited to CAD models, part drawings, assembly drawings, bill of materials, travelers/routers, work instructions, test methods, protocols, and reports
  • Train and certify internal manufacturing personnel
  • Validate manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
  • Lead production transfer activities to contract manufacturers or other internal production centers
  • Ensure manufacturing lines are in compliance with FDA QSR and ISO 13485 regulations, as well as State and Federal safety regulations
  • Track production activities and work closely with vendors and subcontractors to resolve production issues and ensure purchased materials and components meet specifications
  • Establish, monitor, improve and report key performance indicators such process yield, Takt time, total cost, total cycle time, etc.
  • Apply Lean Manufacturing principles to continuously improve production processes
  • Support new product development by providing Design for Manufacturability (DFM) inputs to new product designs, establishing pilot-scale manufacturing for low-volume prototype builds, and building product for design verification and design validation tests 
  • Other tasks, as directed by supervision
 
 
The Qualifications   
                                                                                                                                
  • B.S. degree in an engineering field, M.S. preferred
  • Minimum of 8 years of experience in engineering, medical device manufacturing experience preferred
  • Tooling and fixture design experience
  • Process validation experience
  • Working knowledge of cGMPs, FDA QSR, and ISO 13485 regulations
  • Geometric Dimensioning and Tolerancing (GD&T) and SolidWorks experience
  • Strong project management experience and skills
  • Demonstrated problem-solving skills and methodology
  • Ability to work with little day-to-day direction; must be self-directed and willing to take initiative
  • Must be able to work and communicate effectively across all levels and functions of the organization
  • Lean Manufacturing or similar continuous improvement / World Class Manufacturing methodology required
  • High level of attention to detail

Eargo is an Equal Opportunity Employer committed to hiring a diverse workforce.  We offer a competitive compensation and benefits package including stock options. 

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